Dementia
Conditions
Keywords
Elderly, Dementia, Intervention program
Brief summary
The illness course and symptoms of dementia is usually very long and characterized with behavioral, psychological and physical changes. Family caregivers' stresses change during the illness trajectory as well. The purpose of this study is to compare the costs and effectiveness of two care models- home-based caregiver-training program model and routine care model for dementia elders in Taiwan.
Detailed description
The illness course and symptoms of dementia is usually very long and characterized with behavioral, psychological and physical changes. Family caregivers' stresses change during the illness trajectory as well. Thus, the needs of the elderly persons with dementia and their family caregivers differ in different stage of dementia, and the services they require are multidimensional. According to the researchers' previous 2-year study, behavioral problem management and service utilization were found to be the most difficult and least prepared caregiving activities and the family caregiver's needs for assistance of these two caregiving activities differed in different stage of dementia.The purpose of this study is to compare the costs and effectiveness of two care models- home-based caregiver-training program model and routine care model for dementia elders in Taiwan.
Interventions
OTHERA home-based caregiver-training program
A home-based caregiver-training program consisted of two weekly sessions, each lasting 2 to 3 hours. Following the training sessions, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.
Sponsors
National Science and Technology Council, Taiwan
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(patients) * diagnosed with dementia by a psychiatrist or neurologist * Age 65 years or older * living in a community of northern Taiwan * living in a home setting * scored \>50 on the Chinese version Cohen-Mansfield Agitation Inventory (CMAI).
Exclusion criteria
(patients) * diagnosed with critical illness. Inclusion Criteria:(caregivers) * Primary caregiving responsibility and be at least 20 years old.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caregivers' Self-efficacy | 18 months | The Agitation Management Self-efficacy Scale was used to measure caregivers' self-efficacy for managing dementia patients' agitation. Caregivers were asked how confident they were about handling the problem for each identified behavioral problem and if they believed that they could manage the problem for behaviors that did not occur. Scores range from 42 to 210, with higher scores representing greater caregiver self-efficacy. In this study, Cronbach's alphas ranged from 0.98 to 0.99 at different time points. |
| Caregivers' Preparedness | 18 months | Preparedness was measured by the 10-item Caregiver Preparedness Scale,asks caregivers to rate how well prepared they think they are for seven domains of caregiving. A final question asks for an overall rating of how well prepared caregivers think they are to care for the care receiver. Items are scored on a 5-point Likert scale from 1 (not prepared) to 5 (well prepared). Scores range from 10 to 50, with higher scores representing greater preparedness for caregiving tasks. Validity and reliability of the original Preparedness scale was supported.24 The content validity index for the Preparedness Scale Taiwanese version was 1.0 and Cronbach's alpha for this scale among Taiwanese caregivers was 0.87. Cronbach's alpha in this study was 0.92. |
| Caregivers' Competence | 18 months | A 17-item Competence Scale was used to assess caregivers' knowledge and skills for managing behavioral problems of patients with dementia. Scores range from 17 to 85, with higher scores representing better competence. In this study, Cronbach's alpha ranged from 0.90 to 0.93 at different time points. |
| Dementia Patients' Behavioral Problems | 18 months | Physically aggressive behaviors of dementia patients were measured by the PAB subscale of the Chinese version CMAI, community form, which was shown to be valid and reliable for a Taiwanese sample. Each item (behavioral problem) is scored according to its frequency from 1 (never happens) to 7 (several times per hour). PAB subscale scores range from 7 to 49, with higher scores indicating more physically aggressive behaviors. In this study, the PAB subscale had Cronbach's alpha of 0.55. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caregivers' Quality of Life | 18 months | The Taiwan version of the Medical Outcomes SF-36 was used to measure family caregivers' HRQoL. The SF-36 contains eight generic health concepts: physical functioning (PF), role disability due to physical health problems (RP); bodily pain (BP); vitality (energy/fatigue) (VT); general health perceptions (GH); role disability due to emotional problems (RE); social functioning (SF); and general mental health (MH). Taiwan-specific SF-36 algorithms were used to compute the Mental Component Summary (MCS) and Physical Component Summary (PCS) scores using norm-based (mean = 50, SD = 10) scoring methods. Scores for each scale range from 0 to 100, with higher scores representing better health outcomes. In this study, Cronbach's alphas for the eight scales ranged from 0.81 to 0.99. |
| Caregivers' Depressive Symptoms | 18 months | A 17-item Competence Scale was used to assess caregivers' knowledge and skills for managing behavioral problems of patients with dementia. Scores range from 17 to 85, with higher scores representing better competence. In this study, Cronbach's alpha ranged from 0.90 to 0.93 at different time points. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group Caregivers received general information on dementia care and follow-up phone calls simply to maintain contact, but without any training for developing a behavioral problem-management plan and strategies. | 66 |
| Intervention Group Caregivers received solutions for managing behavioral problems, with referrals to community services and telephone consultation, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.
A home-based caregiver-training program: A home-based caregiver-training program consisted of two weekly sessions, each lasting 2 to 3 hours. Following the training sessions, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated. | 63 |
| Total | 129 |
Baseline characteristics
| Characteristic | Control Group | Intervention Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 16 Participants | 34 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants | 47 Participants | 95 Participants |
| Age, Continuous | 56 year STANDARD_DEVIATION 12 | 55 year STANDARD_DEVIATION 15 | 55 year STANDARD_DEVIATION 14 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 48 Participants | 14 Participants | 62 Participants |
| Sex: Female, Male Male | 18 Participants | 49 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 66 | 0 / 63 |
| serious Total, serious adverse events | 0 / 66 | 0 / 63 |
Outcome results
Primary
Caregivers' Competence
A 17-item Competence Scale was used to assess caregivers' knowledge and skills for managing behavioral problems of patients with dementia. Scores range from 17 to 85, with higher scores representing better competence. In this study, Cronbach's alpha ranged from 0.90 to 0.93 at different time points.
Time frame: 18 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Caregivers' Competence | 51 units on a scale | Standard Error 13 |
| Intervention Group | Caregivers' Competence | 66 units on a scale | Standard Error 8 |
Primary
Caregivers' Preparedness
Preparedness was measured by the 10-item Caregiver Preparedness Scale,asks caregivers to rate how well prepared they think they are for seven domains of caregiving. A final question asks for an overall rating of how well prepared caregivers think they are to care for the care receiver. Items are scored on a 5-point Likert scale from 1 (not prepared) to 5 (well prepared). Scores range from 10 to 50, with higher scores representing greater preparedness for caregiving tasks. Validity and reliability of the original Preparedness scale was supported.24 The content validity index for the Preparedness Scale Taiwanese version was 1.0 and Cronbach's alpha for this scale among Taiwanese caregivers was 0.87. Cronbach's alpha in this study was 0.92.
Time frame: 18 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Caregivers' Preparedness | 33 units on a scale | Standard Deviation 8 |
| Intervention Group | Caregivers' Preparedness | 38 units on a scale | Standard Deviation 6 |
Primary
Caregivers' Self-efficacy
The Agitation Management Self-efficacy Scale was used to measure caregivers' self-efficacy for managing dementia patients' agitation. Caregivers were asked how confident they were about handling the problem for each identified behavioral problem and if they believed that they could manage the problem for behaviors that did not occur. Scores range from 42 to 210, with higher scores representing greater caregiver self-efficacy. In this study, Cronbach's alphas ranged from 0.98 to 0.99 at different time points.
Time frame: 18 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Caregivers' Self-efficacy | 155 units on a scale | Standard Deviation 34 |
| Intervention Group | Caregivers' Self-efficacy | 178 units on a scale | Standard Deviation 26 |
Primary
Dementia Patients' Behavioral Problems
Physically aggressive behaviors of dementia patients were measured by the PAB subscale of the Chinese version CMAI, community form, which was shown to be valid and reliable for a Taiwanese sample. Each item (behavioral problem) is scored according to its frequency from 1 (never happens) to 7 (several times per hour). PAB subscale scores range from 7 to 49, with higher scores indicating more physically aggressive behaviors. In this study, the PAB subscale had Cronbach's alpha of 0.55.
Time frame: 18 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Dementia Patients' Behavioral Problems | 7.89 units on a scale | Standard Deviation 1.66 |
| Intervention Group | Dementia Patients' Behavioral Problems | 7.88 units on a scale | Standard Deviation 1.91 |
Secondary
Caregivers' Depressive Symptoms
A 17-item Competence Scale was used to assess caregivers' knowledge and skills for managing behavioral problems of patients with dementia. Scores range from 17 to 85, with higher scores representing better competence. In this study, Cronbach's alpha ranged from 0.90 to 0.93 at different time points.
Time frame: 18 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Caregivers' Depressive Symptoms | 13 units on a scale | Standard Deviation 12 |
| Intervention Group | Caregivers' Depressive Symptoms | 8 units on a scale | Standard Deviation 7 |
Secondary
Caregivers' Quality of Life
The Taiwan version of the Medical Outcomes SF-36 was used to measure family caregivers' HRQoL. The SF-36 contains eight generic health concepts: physical functioning (PF), role disability due to physical health problems (RP); bodily pain (BP); vitality (energy/fatigue) (VT); general health perceptions (GH); role disability due to emotional problems (RE); social functioning (SF); and general mental health (MH). Taiwan-specific SF-36 algorithms were used to compute the Mental Component Summary (MCS) and Physical Component Summary (PCS) scores using norm-based (mean = 50, SD = 10) scoring methods. Scores for each scale range from 0 to 100, with higher scores representing better health outcomes. In this study, Cronbach's alphas for the eight scales ranged from 0.81 to 0.99.
Time frame: 18 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Caregivers' Quality of Life | PF | 80.22 units on a scale | Standard Deviation 23.48 |
| Control Group | Caregivers' Quality of Life | RP | 67.22 units on a scale | Standard Deviation 47.02 |
| Control Group | Caregivers' Quality of Life | RE | 70.37 units on a scale | Standard Deviation 45.07 |
| Control Group | Caregivers' Quality of Life | SF | 68.06 units on a scale | Standard Deviation 28.27 |
| Control Group | Caregivers' Quality of Life | BP | 72.84 units on a scale | Standard Deviation 25.09 |
| Control Group | Caregivers' Quality of Life | VT | 52.00 units on a scale | Standard Deviation 21.52 |
| Control Group | Caregivers' Quality of Life | MH | 64.09 units on a scale | Standard Deviation 21.65 |
| Control Group | Caregivers' Quality of Life | GH | 50.64 units on a scale | Standard Deviation 27.43 |
| Control Group | Caregivers' Quality of Life | PCS | 51.39 units on a scale | Standard Deviation 9.72 |
| Control Group | Caregivers' Quality of Life | MCS | 50.10 units on a scale | Standard Deviation 10.92 |
| Intervention Group | Caregivers' Quality of Life | GH | 63.75 units on a scale | Standard Deviation 22.22 |
| Intervention Group | Caregivers' Quality of Life | PF | 83.38 units on a scale | Standard Deviation 26 |
| Intervention Group | Caregivers' Quality of Life | VT | 69.75 units on a scale | Standard Deviation 13.77 |
| Intervention Group | Caregivers' Quality of Life | RP | 73.13 units on a scale | Standard Deviation 43.63 |
| Intervention Group | Caregivers' Quality of Life | MCS | 57.85 units on a scale | Standard Deviation 7.11 |
| Intervention Group | Caregivers' Quality of Life | RE | 88.33 units on a scale | Standard Deviation 29.77 |
| Intervention Group | Caregivers' Quality of Life | MH | 72.50 units on a scale | Standard Deviation 13.07 |
| Intervention Group | Caregivers' Quality of Life | SF | 87.50 units on a scale | Standard Deviation 17.68 |
| Intervention Group | Caregivers' Quality of Life | PCS | 52.96 units on a scale | Standard Deviation 10.64 |
| Intervention Group | Caregivers' Quality of Life | BP | 82.25 units on a scale | Standard Deviation 18.75 |